Kornimate/medical-research-clean huggingface dataset:
advair pediatric once-daily

Conditions: Asthma

Summary: to demonstrate if once-daily dosing of advair 100/50 once-daily has superior efficacy and comparable safety compared with fp 100mcg once-daily in pediatric subjects 4 to 11 years of age with asthma.


Eligibility criteria:
inclusion criteria: * out-patients * asthma diagnosis * reversibility * short-acting beta-agonist or asthma controlled medication use exclusion criteria: * life-threatening asthma * specified asthma medications * chickenpox * drug allergy * respiratory infections * tobacco use * clinical laboratory abnormalities * ophthalmologic conditions * investigation medications * affiliation with investigator site
the cxbladder monitoring study

Conditions: Urothelial Carcinoma

Summary: the aim of this trial is to determine the performance characteristics of the cxbladder test for the detection of recurrent urothelial carcinoma (uc) in patients with a recent history of urinary tract uc, who have been treated according to standard practice and are undergoing routine investigative cystoscopy. the gold standard for determination of clinical truth is cystoscopy, plus any follow up investigations relating to the current visit.


Eligibility criteria:
inclusion criteria: * confirmed positive diagnosis for primary or recurrent urinary tract uc over the past 2 years. * patient is undergoing investigative cystoscopies for the monitoring of recurrence of uc at intervals prescribed by a clinical practitioner * patient is 18 years of age or older. exclusion criteria: * prior genitourinary manipulation (cystoscopy / catheterisation / dilation) in the 14 days before urine collection, current urinary tract infection, current or known history of urinary tract inflammatory disorder, recent history of glomerulonephritis, nephrosis or other renal inflammatory disorders, recent history of pyelonephritis * patient has undergone total bladder cystectomy as treatment for bladder uc
blended learning in future physiotherapy professionals

Conditions: Heart Diseases; Teach-Back Communication

Summary: blended learning (bl) is proving to be an effective method of teaching within the health professions . however, there are still scarce studies on bl conducted with undergraduate physiotherapy students. therefore, the aim of this study was to determine the effectiveness of a heart disease bl programme in knowledge, motivation, engagement, design of the programme instructions and learning behaviours in physiotherapy students.


Eligibility criteria:
inclusion criteria: * studying a physiotherapy degree at the aforementioned university * to be willing to participate exclusion criteria: * none

Keywords: blended learning education teaching methods physiotherapy students
comparison of lower-risk mds patients with and without improvements in fatigue following blood transfusion therapy

Conditions: Myelodysplatic Syndromes

Summary: at present, it is unclear why some myelodysplastic patients (mds) receiving blood transfusion therapy exhibit an increase in hemoglobin (hb) without a concurrent improvement in fatigue. research is thus required to elucidate on why fatigue persists in some mds patients in order to devise strategies to alleviate fatigue in "non-responders" to blood transfusion.

one hypothesis is that patients who exhibited persistent fatigue following a blood- transfusion- induced increase in hb have an impaired ability to utilize oxygen at the peripheral level. this could be the consequence of impairments in vascular function, mediated by endothelial dysfunction as a result of transfusion-induced iron-overload and oxidative stress associated with the disease. taking the current gaps in knowledge pertaining to mds-related fatigue into account, the objective of this study is to improve understanding on the aetiology fatigue in mds patients. to achieve this aim, the study will measure a comprehensive group of patient-reported and disease-related outcomes: i) prior to blood transfusion therapy when hb levels are low and; ii) following blood transfusion therapy, when hb levels have been increased. results from the post-transfusion tests will be analyzed to determine which participants remain fatigued despite an increase in hb, and which participants shown an improvement in fatigue.

Eligibility criteria:
inclusion criteria: * patient affiliated to a social security regimen or beneficiary of the same * signed written informed consent form * patient, ≥ 18 years-old, with established diagnosis of myelodysplastic syndrome with low or intermediate-1 risk cytogenetic profile * facit-f score ≤ 34, * indication of blood transfusion. exclusion criteria: * contra-indication to experimental procedures and/or physical exercise, * concomitant cancer diagnosis, * patient under guardianship or deprived of his liberty or any condition that may affect the patient's ability to understand and sign the informed consent * refusing participation.

Keywords: myelodysplatic syndromes elderly fatigue blood transfusion physiopathology
concomitant chemo-radiotherapy followed by midle chemotherapy in stage i/ii extranodal nk/t-cell lymphoma

Conditions: Extranodal NK-T-Cell Lymphoma, Nasal and Nasal-Type

Summary: the purpose of this study is to evaluate the efficacy of concomitant chemoradiation followed by midle chemotherapy for stage i/ii extranodal nk/t cell lymphoma.

concomitant chemo-radiotherapy: radiation 36-44 gy/18-22 fractions (2 gy/fraction) weekly cisplatin 30mg/m2 + n/s 100ml miv over 30min tri-weekly l-asparaginase 4000 iu iv (d1, 3, 5) rest period: 3 weeks midle chemotherapy: repeated every 28 days for 2 cycles d1 methotrexate 3g/m2 + d5w 500ml miv over 6 hours d2-d3 etoposide 100mg/m2 + d5w 500ml miv over 90mins d2-d3 ifosfamide 1000mg/m2 + d5w 100ml miv over 1hr d2-d3 mesna 300mg/m2 + d5w 100ml miv over 15mins (-15min, 4hrs and 8hrs after ifosfamide, total 3 doses) d1-d4 dexamethasone 40mg/d po or iv d4, 6, 8, 14, 10 l-asparaginase 6000iu/m2 + d5w 500ml miv over 2hours

Eligibility criteria:
inclusion criteria: * patients were required to have a biopsy-proven diagnosis of nasal enktl * at least 18 years old * ann arbor stage ie or iie * measurable disease * eastern cooperative oncology group (ecog) performance status of 0-2 life expectancy greater than 12 weeks * adequate hematologic (hemoglobin \> 9.0 g/dl, absolute neutrophil count \> 1,500/ul and platelets \> 100,000/ul) * renal (serum creatinine \ 50 ml/min) * hepatic (total bilirubin \< 2 times of upper limit of normal and aspartate transferase \< 3 times of upper limit of normal) function * diagnosis of enktl is based on the presence of histological features and immunophenotypes compatible with enktl (e.g., cytoplasmic cd3+, cd20-, cd56+, * positive for cytotoxic molecules * positive for ebv by in situ hybridization). * informed consent exclusion criteria: * prior or concomitant malignant tumors * any coexisting medical problems of sufficient severity to prevent full compliance with the study protocol. * enktl with non-nasal sites such as skin or gastrointestinal tract was excluded even if it is localized. * other subtypes of non-hodgkin lymphoma (nhl), including myeloid/nk cell precursor acute leukemia, blastic nk cell lymphoma/precursor nk cell lymphoblastic leukemia, aggressive nk cell leukemia, and peripheral t cell lymphoma, unspecified, were excluded.

Keywords: natural killer cell t cell lymphoma radiation chemotherapy
post-marketing surveillance of olmesartan medoxomil in combination with hydrochlorothiazide

Conditions: Hypertension

Summary: this is a post-marketing surveillance study evaluating the efficacy, tolerability and safety of olmesartan medoxomil 20 mg in combination with 12.5 mg of hydrochlorothiazide in subjects with mild to moderate essential hypertension

non probability sampling

Eligibility criteria:
inclusion criteria: * male and female patients 18 to 65 y/old * patient previously taking low-dose medoxomil or any other arb alone with uncontrolled bp * patient with uncontrolled mild to moderate hypertension (sbp\>= 140 and \ =90 and \<=109 mmhg) exclusion criteria: * pregnant of lactating women * history of secondary hypertension

Keywords: efficacy; tolerability; safety; essential hypertension
effect of snb on the qor in patients undergoing supratentorial tumor resection

Conditions: Postoperative Analgesia; Quality of Recovery; Supratentorial Tumor; Craniotomy; Scalp Nerve Block

Summary: patients with supratentorial tumor undergoing craniotomy have a higher risk of postoperative pain, which will affect their postoperative quality of recovery (qor). although scalp nerve block (snb) can alleviate postoperative pain, the effect on postoperative qor in patients with supratentorial tumor undergoing craniotomy is still unclear. this study is aimed to explore the effect of snb on postoperative qor in this population. to explore the effect, we design a randomized controlled trial in which 84 patients with supratentorial tumor will be randomly assigned to either the snb group or control group. the primary outcome is 15-item qor score at 24 h after surgery. the secondary outcomes include 15-item qor scores at 72 h after surgery, riker sedation-agitation scale, nausea and vomiting, intraoperative opioids and propofol consumption, perioperative heart rate and mean artery pressure, the duration of anesthesia and surgery, time to extubation, pacu duration, the length of postoperative days, adverse events within 72h and total medical expenses.


Eligibility criteria:
inclusion criteria: * age between 18 and 65; * the diagnosis was supratentorial tumor; * scheduled for elective supratentorial craniotomy with general anesthesia ; * the american society of anesthesiologists physical status i-iii; exclusion criteria: * the bmi≦18kg/m2 or bmi≧30kg/m2; * refusing to sign written informed consent; * anticipated surgery duration is too short (\ 6 h); * liver or kidney dysfunction, severe cardiopulmonary failure or nervous system disease ; * with other malignancies ; * severe hematological disease and / or abnormal coagulation function; * fever, systemic and / or scalp infection; * tumors are metastases, aneurysms, hemangioma, or located in the skull base, or located in functional brain areas such as language and movement; * allergy to any drug used in this study; * a history of craniotomy tumor resection; * preoperative usage of antiinflammatory agents or analgesics; * pregnant women, lactating women, illiterate people, people with cognitive impairment, a history of mental illness, unable to communicate and complete the scale assessment; * patients with severe hemodynamic disturbances or other life-threatening complications during the operation, or those transferred to the intensive care unit (icu) after surgery.

Keywords: supratentorial tumor resection scalp nerve block quality of recovery postoperative analgesia
timing of tracheostomy in covid-19 - impact on mortality

Conditions: Tracheostomy

Summary: how timing of tracheostomy in covid-19 patients changed and its impact on mortality in patients with severe covid-19 ards


Eligibility criteria:
inclusion criteria: - severe covid-19 infection requiring endotracheal intubation and prolonged invasive ventilation as part of the treatment of severe to moderate acute respiratory distress syndrome. exclusion criteria: * covid-19 disease, without the need for endotracheal ventilation. * covid-19 disease with need for endotracheal intubation with anticipated short-term invasive ventilation.
single-dose study of black cohosh and red clover

Conditions: Menopause

Summary: this phase i study will assess the pharmacokinetics of two botanicals, trifolium pratense (red clover) and cimicifuga racemosa (black cohosh). participants will receive a single dose of one botanical preparation. the observation period will be one week. drug toxicity, absorption, distribution, metabolism and elimination data will be collected, and dosages to be utilized in a phase ii clinical trial will be determined.

this phase i study will assess the pharmacokinetics of two botanicals, trifolium pratense (red clover) and cimicifuga racemosa (black cohosh). participants will receive a single dose of one botanical preparation. the observation period will be one week. drug toxicity, absorption, distribution, metabolism and elimination data will be collected, and dosages to be utilized in a phase ii clinical trial will be determined. the phase ii trial will examine the efficacies of red clover and black cohosh for the reduction of menopausal symptoms in healthy menopausal women. the study will be randomized, double-blinded, and placebo-controlled. study duration will be one year.

Eligibility criteria:
inclusion criteria: * healthy menopausal women * average body weight * able to give informed consent exclusion criteria: * smoker * use of any prescription medicine within the last 2 months * obesity \> 30% above ideal body weight * previous history of breast or reproductive cancer * alcohol abuse or consumption above 5 glasses of wine per week or equivalent * chronic disease such as diabetes or hypertension * concurrent non-dietary phytoestrogens or hormone use; vegans (vegetarians who tend to consume greater than average dose of phytoestrogens) * concurrent participation in other clinical trial(s) * unavailable for followup

Keywords: menopause hot flashes botanicals
test of the nipro elisio h dialyzer in different dialysis treatment procedures

Conditions: Chronic Kidney Disease

Summary: a current trend in dialysis membrane engineering is to maximize the permeability for larger low-molecular weight proteins while retaining albumin. protein-leaking dialysis membranes do not meet these requirements. particularly in convective procedures, such as hemodiafiltration, their albumin leakage is too high \[10\]. polynephron™, the membrane which is built in to the new nipro elisio® dialyzer, is a new dialysis membrane, produced by applying an innovative spinning technique. the incentive of its development was to improve the characteristics of existing dialysis membranes, i.e., realizing a steeper sieving profile for low-molecular weight proteins without significant loss of essential larger proteins at best biocompatibility properties, for a more adequate dialysis therapy. purpose of the planned study is to demonstrate the superior performance at lower albumin loss in different dialysis procedures of the new nipro elisio® dialyzer compared with a control dialyzer with regard to the removal of the whole range of uremic toxins.


Eligibility criteria:
inclusion criteria: * age ≥18 years * ckd stage 5 with hemodialysis or hemodiafiltration treatment for more than three months * hematocrit \>30 % * routine anticoagulation and erythropoietin regimen * no vascular access related problems (a/v-fistula, graft or bi-flow catheter) * no ongoing infection * signed informed consent form exclusion criteria: * inclusion criteria not met * known hiv or active hepatitis b or c infection (positive pcr). pregnancy * unstable clinical condition (e.g. cardiac or vascular instability) * life expectancy less than 12 months * known coagulation problems * patients participating in another study interfering with the planned study

Keywords: dialysis membrane polynephron elisio h polyethersulfone diapes pes-ds online post-dilution hemodiafiltration hemodialysis protein-bound toxins beta-2-microglobulin hemodialysis patients
oral saha (suberoylanilide hydroxamic acid) in advanced cutaneous t-cell lymphoma (0683-001)

Conditions: Cutaneous T-cell Lymphoma; Sezary Syndrome; Mycosis Fungoides

Summary: a study for patients diagnosed with advanced cutaneous t-cell lymphoma (stage 1b or higher) who have progressive, persistent, or recurrent disease on or following 2 other therapies, one of which must have contained targretin (bexarotene)or for patients who are not candidates or could not tolerate targretin therapy.


Eligibility criteria:
inclusion criteria: * patients with cutaneous t-cell lymphoma (stage 1b or higher) * age: over 18 years of age * have the ability to swallow capsules. * you must be at least 3 weeks from any prior chemotherapy or anticancer therapy treatment and have recovered from any side effects of that treatment. * patients also require adequate heart, liver, and kidney function. exclusion criteria: * pregnant and nursing women and those with known allergy to the study drug are excluded from this study. * patients are excluded if they are currently receiving chemotherapy, radiation therapy, or other investigational anti-cancer therapy. * patients diagnosed with hiv, active hepatitis or who require intravenous antibiotics or antifungal agents are not permitted.

Keywords: ctcl
experimentation of an ankle mobilization device for the rehabilitation of patients with acquired brain injuries.

Conditions: Acquired Brain Injury

Summary: the proposed clinical investigation plan is a randomized controlled pivotal study with 2 parallel groups, has a total duration of two years. for the study, 30 pediatric patients suffering from acquired brain injury will be recruited at the scientific institute eugenio medea. the primary aim of this study is to assess the clinical benefit of using an ankle mobilization device for the rehabilitation of pediatric patients with acquired brain injuries, on its clinical performance and its risks, and on its safety. the efficacy of the treatment will be evaluated in terms of ankle range of motion (primary outcome). the effects of the treatment on musculoskeletal plasticity will be studied using an isokinetic machine and functional magnetic resonance imaging will provide information on variations of reactivity in the motor cortical network. ease of use, safety and usability of the device will also be evaluated.


Eligibility criteria:
inclusion criteria: * tetraplegic and hemiplegic acquired brain injury patients, within first month of injury. * spastic syndrome (ankle joint modified ashworth scale \> 1). exclusion criteria: * pace maker or other contraindication to magnetic resonance imaging scans. * other serious comorbidity. * behaviour and psychiatric disorders.
self-management program and survivorship care plan in improving the health of cancer survivors after stem cell transplant

Conditions: Hematopoietic and Lymphoid Cell Neoplasm

Summary: this phase iii trial investigates health informatics and a self-management program for improving the health of cancer survivors after stem cell transplant. after transplant many survivors may feel stressed or may be unsure of what health care they need. a self-management program called "inspire," along with a personalized survivorship care plan may improve stress and health care for transplant survivors.

outline: patients are randomized to 1 of 2 groups. group i: patients receive immediate access to the inspire online program and personalized survivorship care plan. group ii: patients receive an online program linking to existing online survivor resources and a personalized survivorship care plan. patients receive access to the inspire online program after 12 months.

Eligibility criteria:
inclusion criteria: * received \>= 1 autologous or allogeneic (related or unrelated) hct with curative intent at a participating transplant center for a hematologic malignancy * age 18 years of age or older at last transplant * survival 2-5 years after last hct when first approached for enrollment * in remission at time of study entry, may be receiving chemoprevention * internet and email access * american and canadian citizens, and/or those with mailing addresses in the united states (us)/canada and/or temporarily residing anywhere outside the country (ie - military). exclusion criteria: * development of invasive subsequent malignancy after hct other than non-melanoma skin cancer, in the past two years * medical or other issue prohibiting computer use, reading or ability to comply with all study procedures or unable to communicate via phone (e.g., significant vision, hearing or cognitive impairment, major illness, hospitalization) * residing in an institution or other living situation where health care decisions are not made by the participant (e.g., hospitalized, prisoners, living in a rehabilitation facility) * does not complete baseline patient-reported outcome (pro) assessment items required to determine stratification or whether the survivor meets inclusion and exclusion criteria * non-proficient in english (written and spoken)
nonsurgical periodontal care for diabetes patients: a case-control study

Conditions: Periodontitis; Diabetes

Summary: diabetes mellitus (dm) and periodontitis are two chronic diseases that are interconnected. the coexistence of these conditions leads to increased severity of periodontitis and challenges in controlling blood glucose levels in diabetic patients. the aim of the present study was to evaluate both the influence of periodontal disease and its treatment in patients with dm in terms of a reduction in glycosylated haemoglobin levels at 3 and 6 months after treatment.

a sequential, nonprobabilistic, controlled, prospective and longitudinal case-control study was carried out at the university dental clinic of the morales meseguer hospital in murcia, spain. thirty diabetic patients were divided into two groups. participants were assigned to either the periodontal treatment group (test group), which received oral hygiene instructions along with scaling and root planing utilizing ultrasound and gracey curettes, or the nonperiodontal group (control group), which received oral hygiene instructions along with supragingival removal of plaque and calculus using ultrasound. periodontal and endocrine-metabolic variables were evaluated at baseline and at 3 and 6 months. clinical periodontal variables such as the plaque index (pi), bleeding on probing (bop), periodontal probing depth (ppd), clinical attachment level (cal), and glycosylated haemoglobin (hba1c) levels were assessed.

Eligibility criteria:
inclusion criteria: * the inclusion criteria included individuals who met the following specifications: diagnosed with diabetes mellitus, aged 18 years or older, exhibited moderate or advanced periodontitis (clinical insertion loss of 2 mm interproximally or exceeding 3 mm vestibularly or linguodistally in more than 2 nonadjacent teeth), and possessed an hba1c level between 5.5 and 11. additionally, participants were allowed to participate in the study only if they did not have any significant diabetic complications and completed the informed consent forms indicating their willingness to participate in the present study. exclusion criteria: * the exclusion criteria were as follows: patients previously diagnosed and treated for periodontal disease; pregnant or lactating patients; individuals who had taken antibiotics, antiseptics, or medications that could affect the host response during the month prior to the periodontal assessment; patients with uncontrolled dm; and patients who did not sign the informed consent form.

Keywords: periodontitis; glycosylated haemoglobin; glycaemic control; nonsurgical periodontal therapy; periodontal disease